title: Clinical trial participation as part of end-of-life cancer care: associations with medical care and quality of life near death.
abstract: BACKGROUND
  Clinical trials are a common therapeutic option for patients with advanced incurable cancer.
  
  
  OBJECTIVE
  To examine the associations between trial participation and end-of-life (EOL) outcomes, including aggressive care and quality of life (QOL).
  
  
  METHODS
  Coping with Cancer, a multicenter prospective cohort study of patients with metastatic cancer, progressed after at least first-line chemotherapy. Baseline chart review documented clinical trial participation. Baseline interviews assessed psychosocial characteristics and EOL preferences. Caregiver interview and chart review assessed medical care and QOL near death. The primary outcome was aggressive EOL care (ventilation, resuscitation, or intensive care unit admission in last week of life). Propensity score weighting balanced patient characteristics that differed by trial participation, including care preferences and EOL discussion. Propensity score-weighted regression models estimated the effect of trial participation on outcomes.
  
  
  RESULTS
  Of 352 patients followed to death, 37 were enrolled in a clinical trial at baseline. In propensity score-weighted analyses, trial participation was significantly associated with aggressive EOL care (21.6% vs. 12.0%, adjusted odds ratio [AOR] 2.04, 95% confidence interval [CI] 1.00-4.15), late hospice enrollment (51.4% vs. 42.2%, AOR 1.96, 95% CI 1.10-3.50), hospital death (48.6% vs. 25.7%, AOR 2.74, 95% CI 1.37-5.47), intensive care unit death (16.2% vs. 6.3%, AOR 3.53, 95% CI 1.29-9.65), and inferior QOL near death (least squares mean 5.93 vs. 7.69, P<0.001). Controlling for EOL care, trial enrollment was no longer associated with QOL near death (P=0.342).
  
  
  CONCLUSIONS
  Clinical trial participation is associated with aggressive EOL care. Aggressive EOL care appears to explain the association between trial participation and QOL near death.
authors.affiliation: Center for Psychosocial Epidemiology and Outcomes Research, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; Department of Medical Oncology, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; McGraw/Patterson Center for Population Sciences, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Andrea C
authors.initials: AC
authors.lastname: Enzinger
authors.affiliation: Center for Psychosocial Epidemiology and Outcomes Research, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; McGraw/Patterson Center for Population Sciences, Dana-Faber Cancer Institute, Boston, Massachusetts, USA.
authors.forename: Baohui
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Department of Medical Oncology, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; McGraw/Patterson Center for Population Sciences, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Jane C
authors.initials: JC
authors.lastname: Weeks
authors.affiliation: Center for Psychosocial Epidemiology and Outcomes Research, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; Department of Medical Oncology, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; McGraw/Patterson Center for Population Sciences, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA. Electronic address: holly_prigerson@dfci.harvard.edu.
authors.forename: Holly G
authors.initials: HG
authors.lastname: Prigerson
mesh_terms: D032722:Advance Care Planning; D017028:Caregivers; D002986:Clinical Trials as Topic; D003422:Critical Care; D005260:Female; D017051:Hospice Care; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D057240:Patient Preference; D011446:Prospective Studies; D011788:Quality of Life; D012044:Regression Analysis; D013727:Terminal Care
keywords: Palliative care; cancer; clinical trials; end-of-life care